Rigid delivery systems having inclined ultrasound and needle

Abstract

A delivery system includes a rigid shaft, an imaging core, and an interventional core. The rigid delivery shaft has a proximal end, an angled distal tip, and an axial passage therethrough. The imaging core comprises an ultrasound imaging insert disposed within the axial passage. The imaging insert has an ultrasound array within a distal portion thereof, wherein the ultrasound array is tilted relative to a shaft axis. The interventional core comprises a curved ablation needle coupled to the rigid shaft. An angle of needle curvature may be inversely proportional to the ultrasound array tilt and tip angle.

Description

BACKGROUND OF THE INVENTION[0001]The present invention relates generally to medical systems and methods. More particularly, the invention relates to rigid delivery systems having an inclined ultrasound array for improved imaging and curved needle for ablation treatment and methods for using such systems.[0002]Treatment of the female reproductive tract and other conditions of dysfunctional uterine bleeding and fibroids remain unmet clinical needs. Fibroids are benign tumors of the uterine myometrial (muscle) and are the most common tumor of the female pelvis. Fibroid tumors affect up to 30% of women of childbearing age and can cause significant symptoms such as discomfort, pelvic pain, mennorhagia, pressure, anemia, compression, infertility and miscarriage. Fibroids may be located in the myometrium (intramural), adjacent to the endometrium (submucosal) or in the outer layer of the uterus (subserosal). Most commonly fibroids are a smooth muscle overgrowth that arise intramurally and c...

AI Technical Summary

Benefits of technology

The present invention is a rigid delivery system with an inclined ultrasound array and curved needle for improved imaging and ablation treatment. The system allows for needle deployment into solid tissue under direct visualization and ultrasound imaging. The needle can be selected based on the angle of ultrasound array tilt and shaft bend, providing better access and maneuverability. The curved needle has enhanced pushability, deployability, and penetrability characteristics. The angle of needle curvature can be in a range from about 0 degrees to about 80 degrees. The invention is not limited to blood vessels or other regions of the vasculature.

Problems solved by technology

Fibroid tumors affect up to 30% of women of childbearing age and can cause significant symptoms such as discomfort, pelvic pain, mennorhagia, pressure, anemia, compression, infertility and miscarriage.

All medications are relatively ineffective and are palliative rather than curative.

While effective, hysterectomy has many undesirable side effects such as loss of fertility, open surgery, sexual dysfunction and long recovery time.

There is also significant morbidity (sepsis, hemorrhage, peritonitis, bowel and bladder injury), mortality and cost associated with hysterectomy.

Often these procedures and long with significant blood loss and can only remove a portion of the culprit tissue.

However, laparoscopic myomectomy remains technically challenging, requiring laparoscopic suturing which limits its performance to only the most skilled of laparoscopic gynecologists.

The uterus needs to be filled with fluid for better viewing and thus has potential side effects of fluid overload.

Hysteroscopic ablation is limited by its visualization technique and is thus only appropriate for those fibroids that are submucosal and / or protrude into the uterine cavity.

In addition, long term MRI data suggest that incomplete fibroid infarction may result in regrowth of infarcted fibroid tissue and symptomatic recurrence.

Endometrial ablation destroys the endometrial tissue lining the uterus but does not specifically treat fibroids.

This technique is also not for women who desire future childbearing.

Endometrial ablation remains an excellent therapy for dysfunctional uterine bleeding but is limited in its ability to treat fibroids.

As with all laparoscopic techniques, myolysis treatment is limited by the fact that it can only allow for visualization of subserosal fibroids.

However, the desirability of multiple passes is mitigated by the risk of adhesion formation, which is thought to increase with increasing amounts of injured uterine serosa, and by the operative time and skill required.

Myolysis is generally limited by the fact that it is used with direct visualization and can therefore only see (and therefore treat) subserosal fibroids.

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